Janssen launches Incivo in the UK
pharmafile | October 10, 2011 | News story | Sales and Marketing | Incivek, Incivo
Janssen’s new hepatitis C treatment Incivo has been launched in the UK, one of two new drugs set to advance treatment.
Incivo (telaprevir) is a new direct acting antiviral protease inhibitor (PI), for genotype-1 chronic hepatitis C, and can help clear the virus from many more patients when added to standard treatment, peginterferon alfa and ribavirin.
Trials show that adding Incivo clears the virus in almost twice as many previously untreated patients (79% vs. 46%) and almost four times as many who had previously relapsed following treatment (84% vs. 22%). The drug also halved the current total treatment duration to six months in many (58%) previously untreated patients in trials.
Treatment with peginterferon alfa and ribavirin is successful in only about 50% of patients with genotype 1, leaving half of patients without successful treatment.
But Incivo does not have the market all to itself – a rival treatment, Merck and Roche’s Victrelis (boceprevir), was launched in the UK in August.
Both drugs are oral protease inhibitors, but many analysts predict Incivo will prove to be more favoured because it has shown a higher cure rate, and a simpler and faster simpler dosing regimen. But Janssen and its US marketing partner Vertex (which discovered the drug) will face stiff competition from Victrelis.
Commenting on the launch of Incivo, Professor Graham Foster, Queen Mary’s University Hospital of London said: “This is an exciting time for people living with chronic genotype-1 hep C. Before the introduction of protease inhibitors, of which telaprevir is the latest, treatment for hep C required a long duration and less than 50% of chronic genotype-1 hep C patients got rid of the virus.”
Professor Foster added: “For many adults with chronic genotype-1 hep C, treatment with a telaprevir based regimen could provide a shorter treatment duration with improved response rates compared to standard treatment.”
Speaking on behalf of patients living with hep C, Charles Gore, chief executive of the Hepatitis C Trust said: “Hepatitis C can be a devastating disease; however, if treated successfully, patients can avoid life-threatening liver problems such as further liver damage, cirrhosis, liver failure and liver cancer. The arrival of protease inhibitors is the first major treatment advance in more than 10 years and a significant step forward for the hep C community.”
Chronic hep C is the most common reason for liver transplants in Europe. An estimated 216,000 to 466,000 people in the UK are chronically infected with hep C, yet only 80,000 have been diagnosed. Of those who develop chronic hep C an estimated 30% will develop cirrhosis (deterioration of the liver), others will develop liver cancer, some of whom may require liver transplantation.
The most frequently reported moderate adverse reactions were anaemia, rash, pruritus, nausea, and diarrhoea, and the most frequently reported severe adverse reactions (incidence greater than or equal to 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, pruritus, and nausea.
Rash events were reported in 55% of patients with telaprevir based treatment compared with 33% in the control arm (peginterferon alfa and ribavirin only). More than 90% of rashes were of mild or moderate severity. Severe rashes were reported with telaprevir based treatment in 4.8% of patients. Rash led to discontinuation in 5.8% of patients. Anaemia was reported in 32.1% of patients compared with 15% in the control arm (peginterferon alfa and ribavirin only). It led to discontinuation in approximately 3% of patients.
UK Hepatitis C Map
Janssen has also launched the first ever online “UK Hepatitis C Map,” an interactive map for hep C, available at HelpEveryPersonC.co.uk which provides data on prevalence of hep C by area. It also details of local support groups, treatment centres and stories from people living with hep C and their friends, family and carers. In addition the website offers downloadable questionnaires about hep C which people who have any questions may take to their healthcare professional to aid their discussion about hep C.
Incivo’s launch coincides with news that the Scottish Medicines Consortium has approved Victrelis for use in the NHS in Scotland. NICE is expected to issue its guidance on Incivo and Victrelis in May 2012.
Andrew McConaghie
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